Subject: Snapshot criteria clin.trial. Пожалуйста, помогите перевести.Выражение встречается в следующем контексте: ... Приведенная информация согласуется с данными о влиянии исходной вирусной нагрузки на вирусологическую неудачу в соответствии с критериями эффективности (VFeff) и Snapshot-критериями (VFss)... Заранее спасибо |
Возможно, кому-то пригодится информация - вот, нашел объяснение подходов TLOVR и Snapshot: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf The time to loss of virologic response (TLOVR) method previously used in labeling by the DAVP for determining virologic successes at critical time points has often led to multiple queries between the DAVP and the applicant. Briefly, to be called a virologic success (HIV-RNA less than 50) by TLOVR,19 a subject needed to have an HIV-RNA level below a detection limit on two time points and should not have experienced confirmed rebound (two time points) above the limit. This algorithm was, at times, cumbersome when subjects were less than perfectly adherent or when subjects needed to stop treatment for brief periods. DAVP statistical and clinical reviewers recently completed a project titled “Handling uncertainty in endpoint selection and other endpoint issues.” The goal of the project was to determine if simplified endpoints could be used for approval at Week 48. The team evaluated 18 trials from 7 NDAs with 8,046 patients. Results obtained using the TLOVR algorithm, which used data from every visit to consider the pattern of HIV responses, were compared to a less complicated snapshot approach that only used HIV-RNA data at the visit (window period) of interest. A high concordance between the TLOVR algorithm and snapshot results was observed. Using the TLOVR algorithm, 61 percent of the 8,046 patients remained in the study for 48 weeks and were virologic responders compared to 61 percent of the patients using the snapshot approach; 18 percent were virologic nonresponders using the TLOVR algorithm compared to 17 percent using the snapshot approach and approximately 20 percent discontinued before Week 48 using both approaches. Clinically significant differences between the two methodologies are minimal. |
Snapshot - одномоментный, в одной временной точке, однократный (в противоположность longitude) |
Спасибо, Dimpassy! |
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